(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2013/072763 A3 23 May 2013 (23.05.2013) W P O P C T (51) International Patent Classification: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, A61K 31/4164 (2006.01) A61P 25/00 (2006.01) HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, A61K 9/70 (2006.01) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (21) International Application Number: NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, PCT/IB20 12/002797 RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, (22) International Filing Date: TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, 16 November 2012 (16.1 1.2012) ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (30) Priority Data: UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, 61/560,577 16 November 201 1 (16. 11.201 1) US TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, (71) Applicant: NOMETICS INC. [CA/CA]; Parteq, 1625 MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, Biosciences Complex, Queen's University, Queen's Univer TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, sity Biosciences Complex, Kingston, ON K7L 3N6 (CA). ML, MR, NE, SN, TD, TG). (72) Inventor: ENSCORE, David, J.; 105 Travertine Trail, Al- Published: pharetta, GA 30022 (US). — with international search report (Art. 21(3)) (81) Designated States (unless otherwise indicated, for every (88) Date of publication of the international search report: kind of national protection available): AE, AG, AL, AM, 15 August 2013 AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, < © © (54) Title: NON-SENSITIZING TRANSDERMAL CLONIDINE PATCH (57) Abstract: Disclosed herein are non sensitizing clonidine transdermal patches and methods of treatment using the same. The transdermal patches do not contain LUE92, acetaldehyde and polyethylene terephthalate, which are either irritants to skin, or pre - cursors or irritants to skin. The transdermal patches do not elicit an allergic response in the skin of a subject . PCT/IB20 12/002797 A . CLASSIFICATION OF SUBJECT MATTER IPC: A61K 31/4164 (2006.01) . A 6IK 9/70 (2006.01) . A 6IP 25/00 (2006.01) According to International Patent Classification (IPC) or to both national classification and IPC B . FIELDS SEARCHED Minimum documentation searched (classification system followed by classification symbols) IPC: A61K 31/4164 (2006.01 ) , A61K 9/70 (2006.01 ) , A61P 25/00 (2006.01 ) Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched Electronic database(s) consulted during the international search (name of database(s) and, where practicable, search terms used) Canadian Patent Database, google. ca, (Keywords: clonidine, LlIE, acetaldehyde, polyethylene terephthalate, PET) C . DOCUMENTS CONSIDERED TO BE RELEVANT Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. CN 1186659 A (ZHENG, M . ET AL.) 08 July 1998 (08-07-1998) 1-18, 21-23 espacenet translation to englisli *entire document* CN 191 1222 A; (WU, R. ET AL.) 14 February 2007 (14-02-2007) 1-4, 6-7, 9-1 1, 13-16, 18, 21-23 espacenet translation to englisli *entire document* 1-4, 6, 9-1 1, 13-16, 18, 21, 23 CN 10101 1391 A ; (ZHIHUI, C. ET AL.) 08 August 2007 (08-08-2007) espacenet translation to englisli *entire document* U S 4765974 B (TOKUDA, S. ET AL.) 23 August, 1988 (23-08-1988) 1-3, 6, 9-10, 13, 23 ♦abstract, column 1, line 63-, column 2, line 45; column 4, lines 18-19; examples 1, 2* EP 427877 Al; (LOKUDA, S.) 22 May 1991 (22-05-1991) ♦abstract, page 1, lines 4-6; page 3, line 9-26; page 5, line 11-12; page 7, line 56-57; page 8 line 1-8* [x] Further documents are listed in the continuation of Box C . See patent family annex. Special categories of cited documents : later document published after the international filing date or priority date and not conflict with the application but citecTto understand document defining the general state of the art which is not considered the principle or theory underlying the invention to be of particular relevance document of particular relevance the claimed invention cannot be earlier application or patent but published on or after the international considered novel or cannot be considered to involve an inventive filing date step when the document is taken alone document which may throw doubts on priority claim(s) or which is document of particular relevance the claimed invention cannot be cited to establish the publication date of another citation or other considered to involve an inventive step when the document is special reason (as specified) combined with one or more other such documents such combination being obvious to a person skilled the art document referring to an oral disclosure use. exhibition or other means document member of the same patent family document published prior to the international filing date but later than the priority date claimed Date of the actual completion of the international search Date of mailing of the international search report 19 March 20 1 ( 19-03-20 13) 09 April 2013 (09-04-2013) Name and mailing address of the ISA/CA Authorized officer Canadian Intellectual Property Office Place du Portage I, C I 14 - 1st Floor, Box PCT Lily Y u (819) 934-0070 50 Victoria Street Gatineau, Quebec K1A 0C9 Facsimile No.: 001-819-953-2476 Form PCT/ISA/210 (second sheet ) (July 2009) Page 4 of 7 . PCT/IB20 12/002797 Box No. II Observations where certain claims were found unsearchable (Continuation of item 2 of the first sheet) This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons : 1. [X] Claim Nos. : 24-49 because they relate to subject matter not required to be searched by this Authority, namely : Claims 24-49 relate to a method of medical treatment, which the International Search Authority is not required to search under Ar ticle 17(2)a(I) and Rule 39. 1 (iv) of the Patent Cooperation Treaty Regulations. This authority has nevertheless conducted a search based on the alleged therapeutic effect derived from the use of a transdermal patch comprising compound of formula I, wherein the patch does not contain LUE92, acetaldehyde and/or polyethylene terephthalate 2 . [ ] Claim Nos. : because they relate to parts of the international application that do not comply with the prescribed requirements to such an extent that no meaningful international search can be carried out, specifically : 3. [ ] Claim Nos. : because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4( a). Box No. Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet) This International Searching Authority found multiple inventions in this international application, as follows : 1. [ ] As all required additional search fees were timely paid by the applicant, this international search report covers all searchable claims. 2 . [ ] As all searchable claims could be searched without effort justifying additional fees, this Authority did not invite payment of additional fees. 3. [ ] As only some of the required additional search fees were timely paid by the applicant, this international search report covers only those claims for which fees were paid, specifically claim Nos. : 4 . [ ] No required additional search fees were timely paid by the applicant. Consequently, this international search report is restricted to the invention first mentioned in the claims; it is covered bv claim Nos. : Remark on Protest [ ] The additional search fees were accompanied by the applicant's protest and, where applicable, the payment of a protest fee. [ ] The additional search fees were accompanied by the applicant's protest but the applicable protest fee was not paid within the time limit specified in the invitation. [ ] No protest accompanied the payment of additional search fees. Form PCT/ISA/210 (continuation of first sheet (2)) (July 2009) Page 2 of 7 C (Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. US 4822617 Bl; (PANOZ, D. ,E.) 18 April 1989 (18-04-1989) 1-3, 6, 7, 9-10, 13-15, 18, 21-23 ♦abstract, column 1, lines 10-15, 35-43; column 2, line65- column 3, line 54; column 5, lines 8- 15, 65-68; column 6, line 1-5; claim 1* US 2009 0062754 Al; (TANG, J.) 05 March 2009 (05-03-2009) 19, 20 abstract, paragraphs [0009]-[0010], [0026]-[0027], [0065], [0085]-[0088], claims 1, 5, 6, 8 and 16* US 420121 1 B; (CHANDRASEKARAN , S. ET AL) 06 May 1980 (06-05-1980) 19, 20 ♦abstract, column 2, line 4-column 3, line 15; column 4, line 50-column 6, line 8; claims, 1-4, 8 and 9* MAIBACH, H.; Clonidine: Iritant and allergic contact dermatitis assays.; Contact Dermatitis: Vol.